PRACTICES

Other Special Regulatory Programs

Overview:

Globalization and the emergence worldwide of sophisticated chemical management programs invite complex legal, commercial, and scientific challenges. In addition to comprehensive national regulations such as the Toxic Substances Control Act (TSCA) in the U.S., the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) legislation in the European Union (EU), and Chinese regulation under the Provisions on Environmental Administration of New Chemical Substances, there are also trans-national agreements and mechanisms requiring compliance, regulations enforced by authorities other than the national environment and chemicals agencies, and numerous smaller programs that impact the ability of a company to get its products to market. These special regulatory programs are just as important as the major regulations, and can be even more difficult to navigate successfully due to their relative obscurity.

The Acta Group (Acta®) delivers vital expertise in business strategy development and compliance planning for special regulatory programs including:

  • The Codex Alimentarius, an internationally recognized compilation of food standards developed by the Codex Alimentarius Commission (Codex) under the United Nations as a joint project of the Food and Agriculture Organization (FAO) and the World Health Organization (WHO).
     
  • Harmonized Offshore Chemical Notification Format (HOCNF), a program implemented by the OSPAR Commission through the OSPAR Convention, by which 15 Governments of the western coasts and catchments of Europe, together with the EU, cooperate to protect the marine environment of the North-East Atlantic.
     
  • Toxicity Reports, Technical Reports, and the Report on Carcinogens prepared by the National Toxicology Program (NTP), an interagency program established by the U.S. Department of Health and Human Services (HHS) whose mission is to evaluate agents of public health concern by developing and applying tools of modern toxicology and molecular biology.
     
  • The Occupational Safety and Health Administration (OSHA) Lead Standard, which establishes permissible exposure limits (PEL) for lead ingestion or inhalation for workers exposed to lead as a result of the production, use, maintenance, recycling, and disposal of lead material and products. Lead exposure occurs in most industry sectors, including construction, manufacturing, wholesale trade, transportation, remediation, and even recreation.

These are just a few of the many chemical regulatory programs that must be considered. Failure to anticipate and comply efficiently with any of these chemical management programs can be costly. Acta professionals have extensive knowledge of and experience with these programs and offer clients legal, regulatory, and scientific expertise to achieve competitive advantage.

Our Experience:

Acta professionals are business leaders, scientists, regulatory consultants, and policy experts with a wealth of experience at global chemical companies, laboratories, and government agencies. They assist clients in bringing products to market, and responding effectively to matters that may arise over the course of a product’s life.

Karin F. Baron, MSPH, has spent 15 years in the chemical and personal care industry and has experience in ecotoxicology with respect to testing and evaluating substances and mixtures. She researches the criteria and exemptions that apply to OSPAR HOCNF and develops and delivers training to customers on the specifics of the program.

Lynn L. Bergeson counsels corporations, trade associations, and business consortia on a wide range of issues pertaining to chemical hazard, exposure and risk assessment, risk communication, minimizing legal liability, and evolving regulatory and policy matters pertinent to products of conventional, biotechnology, biobased chemicals, nanotechnologies, and other emerging technologies. She has considerable experience advising clients on matters related to the Report on Carcinogens (RoC) science and advocacy issues, and the Codex Alimentarius.

Christopher R. Bryant has decades of experience helping clients comply with the general OSHA standards for lead exposure in the workplace and more specific lead standards, such as the OSHA standard for secondary lead smelters and the standard for lead acid battery manufacturers. Mr. Bryant is a past president of The Technical Group, LLC, which specialized in hazardous waste, hazardous substance, and OSHA matters, and has provided consulting services on OSHA regulatory programs for many industry leaders.

Lisa M. Campbell has more than 20 years of experience addressing pesticide and chemical product approval, defense, and regulatory issues, including NTP and Codex Alimentarius matters. Ms. Campbell directs appropriate internal and external expert technical, policy, public relations, and other legal resources and applies them to client issues so that effective and efficient solutions are developed and implemented.

For nearly two decades, Carla N. Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Acta clients. Ms. Hutton tracks the testing status of chemicals of concern at NTP, as well as nominations to the RoC.

Jane S. Vergnes, Ph.D., a Senior Toxicologist with 25 years of experience in global product stewardship at major international chemical companies, offers expert assistance to clients engaged with NTP.

Jason Johnston, M.S., holds two Master of Science degrees in Chemical Engineering Practice and in Technology and Policy from the Massachusetts Institute of Technology. He has more than 25 years of experience in the field of risk assessment and has served as the project manager/senior scientist for a diverse range of risk assessments. Mr. Johnston is well-versed in the preparation of occupational, individual, aggregate, and cumulative residential and consumer product exposure assessments.

What We Do:

Acta professionals are highly experienced in compliance planning and in scientific, regulatory, and business strategy development for special regulatory programs. Areas in which we advise clients include the following:

  • Codex Alimentarius –
    • Provide technical and strategic guidance in Codex meetings
    • Prepare risk assessments required by Joint FAO/WHO Meeting on Pesticide Residues (JMPR)
    • Monitor developments as they relate to tolerance development by the U.S. Environmental Protection Agency (EPA)
    • Prepare technical and scientific position papers for submission to the Codex Committees
  • Harmonized Offshore Chemical Notification Format (HOCNF) –
    • Advise clients on the requirements of the OSPAR HOCNF processes
    • Review client products for applicability of the OSPAR HOCNF program on a country-specific basis
    • Assist in preparation of OSPAR HOCNF applications, including completion of any required testing
    • Assist clients in navigating their products through the requirements of applicable OSPAR Competent Authority processes
  • National Toxicology Program (NTP) Testing –
    • Prepare scientific and advocacy comments, position papers, and related advocacy documents in connection with the NTP's characterization and evaluation of the toxicologic potential of a chemical
    • Audit testing results that have led to or contributed to a finding that a chemical is a reproductive or developmental toxicant or carcinogen as the terms are defined for NTP purposes
    • Engage in advocacy interventions challenging NTP's scientific findings for purposes of issuance of the RoC
  • Occupational Safety and Health Administration (OSHA) Lead Standard –
    • Audit facilities and supply chain partners for OSHA compliance and related purposes. Conduct advocacy with OSHA and state labor agencies on regulatory issues
    • Develop and implement health and safety management systems
    • Conduct executive level briefings on the importance of compliant and sustainable health and safety programs
    • Review data and test results on workplace safety and health issues
    • Monitor developments at OSHA and maintain relationships with OSHA personnel
    • Model emissions from lead stationary and fugitive sources and assess the legal significant of those results

Representative Engagements:

  • Codex Alimentarius –
    • Collaborated extensively with an international team to develop and obtain Maximum Contaminant Levels (MCL) for many pesticides on behalf of pesticide registrants.
    • Prepared and supported technical dossiers generated as part of a collaborative effort to address advocacy in various Codex meetings.
    • Prepared risk assessments submitted to Codex Committees developing MCLs for various pesticides.
  • Harmonized Offshore Chemical Notification Format (HOCNF) –
    • Prepared comprehensive review of OSPAR HOCNF requirements.
    • Trained staff via a hosted webinar on details of how the HOCNF process works.
    • Developed tailored strategies for applications, exemptions, and communications with OSPAR Competent Authorities.
    • Provided direct assistance in contacting appropriate Competent Authorities to address specific issues.
  • National Toxicology Program (NTP) Testing –
    • Prepared dozens of comments on various regulatory matters involving many different chemicals and challenged NTP's technical findings regarding toxicology and cancer classifications.
    • Developed strategies for chemical consortia to undertake when challenging NTP toxicology or cancer classifications, from the point of NTP testing to the determination by the Secretary of HHS for a chemical's inclusion in the RoC.
    • Audited NTP testing procedures and data for purposes of rebutting the technical bases of NTP toxicology and cancer classifications.
  • Occupational Safety and Health Administration (OSHA) Lead Standard –
    • Commented on PELs.
    • Conducted OSHA compliance audits.
    • Provided advocacy on industry-specific OSHA standards.
    • Coordinated multiple industry response to OSHA regulatory programs.
 
THE ACTA GROUP, L.L.C.
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